Proposed indication 适应症

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August undefined, 2024

Webb(b) paediatric investigation plan indication: the proposed indication(s) in the paediatric population for the purpose of a paediatric investigation plan, and at the time of paediatric investigation plan submission. It should specify if the medicinal product is intended for diagnosis, prevention or treatment of a condition; WebbIndicate if relevant CHMP guidance/CHMP advice has been followed or if any deviations have been made or proposed. Indicate applicability and status of the Paediatric Investigation Plan (with or without deferral or waiver). Indicate availability and need for development in other special populations such as the elderly, male/female and ethnic ...

Type-II variations: questions and answers - European …

http://www.foodmate.net/english/resource/162442.html Webb药融云医药数据库V4.0系统——适应症查询方法（题主涉及的受理号与批准文号查询方式同样适用）. ①进入药融云医药数据库企业版-->药品研发-->全球药物研发. 全球药物研发. ②搜索框输入药品名称，如：阿替利珠单抗，可以查到相关品种有2种，适应症58种 ... hughston clinic athenahealth

适应症 - Wiktionary

WebbC.4.1 L'indication principale approuvée (ou l'indication proposée lorsque le produit n'a pas encore [...] obtenu son Avis de conformité) doit être déterminée pour que puisse être … Webb(c) proposed therapeutic indication: the therapeutic indica-tion in adults and/or paediatric populations as proposed in the paediatric investigation plan at the time of submission of … Webb适应症/適應症 [Pinyin] shì yìng zhèng [English meaning] indication/adaptation disease hughston clinic after hours

Provisional determination eligibility criteria Therapeutic Goods ...

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Webb9 juni 2024 · Proposed indication (s) or context of product development Type of meeting being requested (i.e., Type A, Type B, or Type C). If a Type A meeting is requested, the rationale should be included A brief statement of the purpose and objectives of the meeting A proposed agenda A list of proposed questions grouped by discipline. WebbThe indication proposed at determination may be different to that approved at the time of registration as a result of the assessment of the quality, safety and efficacy data submitted with the registration submission for provisional registration, but must be a related indication. Provisional determination for one indication and one medicine hughston clinic auburnWebbIndication versus condition If a proposed indication, to be submitted under article 8, is part of a condition for which a PIP (or waiver) Decision has already been issued for the … holiday inn express merced reviews

"Webb适应症 II-IV级脑肿瘤（包括胶质母细胞瘤） Indication Grade II-IV brain tumours (including glioblastoma) 该适应症获得加速审批的依据是肿瘤缓解率和缓解持续时间。 This … " - Proposed indication 适应症

Proposed indication 适应症

Applying for new indications Therapeutic Goods Administration …

Webb21 dec. 2024 · There is generally no requirement to notify the Agency in advance of an upcoming submission of a type II variation.For type II variations entailing additions of new therapeutic indication(s) or … WebbProposed Indication KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC), in combination with

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Webbharrison's principles of internal medicine. Term. 1 / 62. integrate. Click the card to flip 👆. Definition. 1 / 62. 整合. Click the card to flip 👆. Webb句子与 «proposed indication» The large majority of plans remained in limbo without any executive indication as to whether they had been approved or not. 大多数计划仍处于不 …

Webb108 indication that is broader or narrower in scope than the precise population studied.6 Applicants 109 should discuss the scope of a proposed indication with the applicable … Webb7 juli 2024 · 目前K药已在全球获批近30个适应症，囊括一线、二线及多线治疗。. 国内表现亦不俗，K药在国内5大瘤种获批7项适应症，是目前中国市场上市的PD-1产品中获批适应症最多的产品。. 获批了包括肺癌、头颈部癌、食管鳞癌、黑色素瘤等癌种治疗，除了食管癌和 …

Webb3 aug. 2011 · Major（Principal）Indications 主要适应症 Uses用途 Action and Use作用与用途偶尔也会见到其他的表示方法。本项中出现频率最高的是疾病名称以及微生物（尤其 … Webb查阅资料了解，适应症为医学名词，英文单词为indication，又叫指征，指药物、手术等方法适合运用的范围、标准。《药学名词》对于适应证的定义是指药物适用于某种疾病症状（或证候）的范围。一般需经相关主管部门审批，是药物的最基本属性。中国最权威的文字工具书《辞海》（1989年版）是这样注释的：适应证指适合于采用某一治疗措施的疾病或情 …

WebbThe indication proposed for Atosiban SUN is the same as authorized for the reference medicinal product: to delay imminent pre-term birth in pregnant adult women with: • regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes

Webb22 nov. 2015 · 推荐律师服务：若未解决您的问题，请您详细描述您的问题，通过百度律临进行免费专业咨询 holiday inn express mercury way manchesterWebbThe proposed indication is for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older and adults. eisai.com … hughston clinic at tristar skylineWebbproposed indication in adults would ignore potential unmet needs and paediatric use based on the properties of the medicine. This was confirmed by the Court of Justice in its … hughston clinic albany ga doctorsWebb23 juni 2024 · 对此，国家新药（抗肿瘤）临床研究中心主任、中国医学科学院肿瘤医院徐兵河教授表示：“对于her2阳性复发或转移性乳腺癌患者，抗her2治疗仍然是治疗的基石，但是依然存在二线方案疗效有限的困境。 adc类药物的出现为her2阳性晚期乳腺癌患者增添了强有力的治疗选择，赫赛莱 ® 填补了我国在 ... hughston clinic and athena healthcareWebb28 feb. 2024 · the proposed indication would widen access to appropriate medications for the treatment of psoriasis and provide an effective alternative for the many patients with mild to moderate forms of this chronic condition who comprise the majority of cases. holiday inn express merchandise mart chicagoWebb句子与 «proposed indication» The large majority of plans remained in limbo without any executive indication as to whether they had been approved or not. 大多数计划仍处于不确定状态，没有任何行政部门表示是否已批准。 holiday inn express meridianWebbIn practice: discussion on each condition/indication and formulation, for each paediatric subset (not only age -groups). Formulation Toxicology, PK, PD, carcino, genotox juvenile … hughston clinic after hours clinic